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Canada Proposes New Device Regs to Improve Safety

June 28, 2019

Health Canada has launched a new consultation on proposed regulations that could impose additional requirements on devicemakers to make their products safer.

Under the proposal, devicemakers could be requested to conduct additional assessments and to provide additional analyses and post-market reviews of their products.

The proposal calls for manufacturers to prepare annual summary reports of all known adverse events, reported problems, incidents, risks, and to notify Health Canada if there has been a change to the risks and benefits of a product.

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